drugset / Trial / NCT02119091
Race Difference Moxifloxacin-induced QT Prolongation Between Healthy Chinese and Caucasian Volunteers
Phase 1
Unknown
80 enrolled
Haiyan Li
BioClinica, Inc. · collabFood and Drug Administration (FDA) · collabPeking University · collabSpaulding Clinical Research LLC · collab
RandomizedCrossoverTriple-blindTreatment
Summary
A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study: Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy Chinese volunteers and Caucasian Volunteers Study Objective:Primary Objective:To compare the difference of ΔΔQTcF (Baseline-adjusted, placebo-corrected effect on QTcF) between Chinese group and Caucasian group under the same exposure (Cmax) of Moxifloxacin.Secondary Objectives:1)To compare the difference of ΔΔQTcF, heart rate, PR, RR, QRS and Moxifloxacin plasma concentration between Chinese group and Caucasian group.2)To compare slopes of Moxifloxacin plasma Concentration/QTcF value between healthy Chinese volunteers and Caucasian Volunteers.
Timeline
- Start
- 2014-04
- Primary completion
- 2014-06
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |